FDA Approves First Generic of Advair Diskus

Megan Brooks

Disclosures

January 30, 2019

The US Food and Drug Administration (FDA) has approved the first generic version of GlaxoSmithKline's Advair Diskus (fluticasone propionate/salmeterol inhalation powder) for the twice-daily treatment of asthma in patients as young as age 4 and for maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD).

The generic, made by Mylan, comes in three strengths: fluticasone propionate 100 μg/salmeterol 50 μg, fluticasone propionate 250 μg/salmeterol 50 μg, and fluticasone propionate 500 μg/salmeterol 50 μg.

"Today's approval of the first generic drug product for one of the most commonly prescribed asthma and COPD inhalers in the US is part of our longstanding commitment to advance access to lower cost, high-quality generic alternatives," Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, said in a news release.

"People living with asthma and COPD know too well the critical importance of having access to the treatment they need to feel better. Today's approval will bring more competition to the market which will ultimately benefit the patients who rely on this drug," Woodcock added.

The FDA requires appropriate data and information to demonstrate that complex generic drug-device combination products such as Advair meet the agency's rigorous approval standards to ensure quality drug products as safe and effective as their brand name counterparts are available to patients, the agency explained.

"The FDA recognizes challenges companies face when seeking to develop hard-to-copy complex generics, such as drug-device combination products, including when the drugs are incorporated into inhalation devices like this," Anna Abram, PhD, FDA's deputy commissioner for Policy, Planning, Legislation, and Analysis, said in the release.

"We are committed to advancing new guidance for sponsors to make the development of generic versions of complex products more efficient, and we're prioritizing review of many applications covering proposed generic complex products for which a generic has not yet been approved," said Abram.

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